EU Member States Have 60 Days Until New Patient Safety-Driven Single Use Medical Device Reprocessing Regulations Go Into Effect
Absent Member State action, in-house reuse of single-use devices must cease by May 26, 2020.
- All “In-House” Hospital Reuse of Single-Use Devices Must Stop by May 26, 2020, Absent Member State Action
- Member States that Opt-In to Use Remanufactured Devices Expected to Save Millions of Euros that May Help Fund Emergency Pandemic Preparedness
- Belgium, Netherlands and UK Completed Review and Adopted Remanufacturing; Review Process Underway in Ireland, Germany, Portugal, Spain and Sweden
BERLIN, March 25, 2020 (GLOBE NEWSWIRE) -- Hospital supply chain and health system experts are urging EU Member States to adopt the new remanufacturing (also known as reprocessing) provisions of the European Medical Device Regulation (MDR) to address patient safety. Absent Member State action, “in-house” reuse of single-use devices must cease by May 26, 2020. The Regulation provides an opportunity for hospitals to unlock millions of Euros in annual savings and reduce medical waste by allowing professionally remanufactured (CE marked) single-use medical devices.
By “opting-in” to Article 17 requirements holding remanufactured SUDs to the same requirements as original equipment, hospitals can unlock millions of euros annually by switching from unvalidated and potentially unsafe in-hospital reprocessing to external, professional remanufacturers of “single-use” medical devices (SUDs).
Currently, devices labeled by the original manufacturer for single-use or as disposable are either used once and discarded or cleaned and reused by the hospital, a practice that was outlawed over safety concerns in the United States 20 years ago.
Already a well-established practice in Germany, the United States and Canada, professional remanufacturing of SUDs has doubled annually for 20 consecutive years. In 2018, hospitals saved over €436m through the regulated use of remanufactured SUDS, according to the Association of Medical Device Reprocessors (AMDR), the global trade association representing professional remanufacturers of SUDs. The UK adopted the practice in 2016, Belgium and Netherlands have already approved the use of remanufactured devices, and Ireland, Germany, Portugal, Spain, and Sweden are under review. Other countries are expected to follow.
“In our experience, when regulatory officials investigate the safety and capabilities of professional remanufacturing, they always choose it over in-house reprocessing,” said Daniel J. Vukelich, President and CEO of the Association of Medical Device Reprocessors. “We look forward and seek opportunities to meet with health officials to explain the differences between SUDs reprocessing by hospitals and regulated remanufacturing.”
Until now, there has not been a single EU-wide policy on the reuse of SUDs. The new EU MDR seeks to ensure that remanufactured devices meet certain standards. The new MDR requires that commercial remanufacturers meet the same standards as makers of original equipment. But EU Member States must elect to allow such products on their individual markets.
“We started using professionally remanufactured SUDs in 2013,” said Maria Graça Rente, RN and Operating Chief Nurse, Centro Hospitalar de São João, Porto, Portugal. “Since then, we’ve saved just for example for one product alone near to €1 million Euros with no increased risk to patient safety. Our surgical team doesn’t mind helping to sort used products if it means such substantial benefits.”
“AMDR has received inquiries from EU member state health Ministries seeking clarification, and we’re pleased to help bring the EU professional remanufacturing industry in line with the successful practice in North America,” said Mr. Vukelich.
While the U.S. Food and Drug Administration and other governmental regulatory authorities have long determined that regulated remanufacturing of certain SUDs is safe, additional new research from England and Portugal further confirms those findings.
About AMDR
Founded 20 years ago, AMDR is the global trade association consisting of members of the regulated, professional single-use device remanufacturing industry. AMDR represents the remanufacturing industry, promotes remanufacturing as an important healthcare strategy that helps hospitals and healthcare providers increase quality, reduce costs and improve patient care, and protects the interests of its members in regulation, legislation and standard-setting.
AMDR members include Innovative Health, Medline Renewal, NEScientific, ReNu Medical, Stryker Sustainable Solution, Sustainable Technologies (a Cardinal Health Business), and Vanguard AG.
Having played a key role in the establishment of the remanufacturing industry, AMDR continues to push the medical technology industry and lead the way for remanufacturing to play a defining role in the evolution and utilization of new device technologies.
Contact: David Sheon for AMDR [email protected] +1 2024226999
